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    Summary
    EudraCT Number:2020-004225-22
    Sponsor's Protocol Code Number:CSEG101A2401B
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-22
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-004225-22
    A.3Full title of the trial
    An Open-label, Multi-center, Phase IV, Rollover Study for Patients with Sickle Cell Disease who have Completed a Prior Novartis-Sponsored Crizanlizumab Study
    Estudio de extensión de fase IV, multicéntrico y abierto para pacientes con enfermedad de células falciformes que hayan completado un estudio anterior de crizanlizumab promocionado por Novartis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rollover Study for Patients with Sickle Cell Disease who have Completed a Prior Novartis-Sponsored Crizanlizumab Study
    Estudio de extensión para pacientes con enfermedad de células falciformes que hayan completado un estudio anterior de crizanlizumab promocionado por Novartis.
    A.4.1Sponsor's protocol code numberCSEG101A2401B
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04657822
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493306 44 64
    B.5.5Fax numberNA
    B.5.6E-maileecc.novartis@novartis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/12/1034
    D.3 Description of the IMP
    D.3.1Product namecrizanlizumab
    D.3.2Product code SEG101
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCRIZANLIZUMAB
    D.3.9.2Current sponsor codeSEG101
    D.3.9.4EV Substance CodeSUB188615
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sickle Cell Disease
    Enfermedad de células falciformes
    E.1.1.1Medical condition in easily understood language
    Sickle Cell Disease
    Enfermedad de células falciformes
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10040644
    E.1.2Term Sickle cell disease
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10002077
    E.1.2Term Anaemia sickle cell
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To allow access of crizanlizumab to patients with SCD who are on crizanlizumab treatment in a Novartis-sponsored study
    Permitir el acceso a crizanlizumab a los pacientes con ECF que estén en tratamiento con crizanlizumab en un estudio promocionado por Novartis.
    E.2.2Secondary objectives of the trial
    To assess the overall safety of crizanlizumab in SCD patients
    Evaluar la seguridad global de crizanlizumab en pacientes con ECF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent/assent, according to local guidelines, signed by the adult patients. In the population under 18 years, it will be signed by the patient and/or by the parents or legal guardian prior to enrolling in the rollover study and receiving study medication
    2. SCD patient currently enrolled in a Novartis-sponsored study receiving crizanlizumab and has fulfilled all the requirements in the parent study. Patient is currently benefiting from the treatment with crizanlizumab as determined by the investigator and has completed the treatment schedule as planned in the parent study
    3. Patient has demonstrated compliance to the planned visit schedule in the parent study, and in the opinion of the investigator has shown willingness and
    ability to comply with future visit schedules
    1.Consentimiento/asentimiento informado por escrito, según las directrices locales, firmado por los pacientes adultos.En la población menor de 18 años de edad, lo firmará el paciente o los progenitores o tutor legal antes del reclutamiento en el estudio de extensión y de recibir la medicación del estudio.
    2. Pacientes con ECF actualmente incluidos en un estudio promocionado por Novartis en el que estén recibiendo crizanlizumab y que hayan cumplido todos los requisitos del estudio principal. Pacientes beneficiándose actualmente del tratamiento con crizanlizumab según el criterio del investigador y que hayan completado el calendario de visitas del tratamiento del estudio principal.
    3. Pacientes que hayan cumplido el calendario de visitas del estudio principal y que, según el investigador, hayan mostrado voluntad y capacidad para cumplir los calendarios de visitas futuros.
    E.4Principal exclusion criteria
    1. Patient had permanently discontinued from crizanlizumab study treatment in the parent study before the parent study completion
    2. Ongoing/unresolved treatment-related Grade 3 or higher AEs, and/or any ongoing AE requiring dose interruption. Patients meeting all other eligibility criteria
    may be enrolled once toxicities have resolved unless those toxicities were grade 4
    3. Concurrent participation in any other investigational clinical trial other than the parent study or plan to participate in any other investigational clinical trial
    4. Pregnant or nursing women
    5. Women of childbearing potential who are unwilling to be on highly effective contraceptives during dosing and until 15 weeks after stopping treatment with crizanlizumab
    6. SCD patients who do not meet parent study protocol criteria to continue with crizanlizumab
    1. Pacientes que haya discontinuado de manera permanente el tratamiento con crizanlizumab en el estudio principal antes de su finalización.
    2. AA en curso/no resueltos de grado 3 o más elevado y relacionados con el tratamiento, o cualquier AA en curso que requiera la interrupción de dosis. Los pacientes que cumplan todos los demás criterios de elegibilidad podrían ser reclutados una vez se hayan resuelto las toxicidades a menos que fueran de grado 4.
    3. Participación concomitante o previsión de participar en algún otro ensayo clínico de investigación que no sea el estudio principal.
    4. Mujeres embarazadas o en periodo de lactancia.
    5. Mujeres con capacidad de quedarse embarazadas que no deseen utilizar métodos anticonceptivos altamente eficaces durante la administración de crizanlizumab y hasta 15 semanas después de finalizar dicho tratamiento.
    6. Pacientes con ECF que no cumplan los criterios del protocolo del estudio principal para continuar con crizanlizumab.
    E.5 End points
    E.5.1Primary end point(s)
    N/A
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    E.5.2Secondary end point(s)
    Frequency, severity and causality of treatment emergent adverse events
    Frecuencia, gravedad y causalidad de los acontecimientos adversos que aparezcan con el tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    from day of first dose of study medication to 105 days after last dose of study medication
    Desde el día de la primera dosis hasta 105 días después de la última dosis de medicación del estudio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To allow access of crizanlizumab to patients with sickle cell disease (SCD) who are on crizanlizumab treatment in a Novartis-sponsored study.
    Permitir el acceso a crizanlizumab a los pacientes con enfermedad de células falciformes (ECF) que estén en tratamiento con crizanlizumab en un estudio promocionado por Novartis.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bahrain
    Brazil
    Canada
    Colombia
    Egypt
    Ghana
    India
    Kenya
    Lebanon
    Oman
    Panama
    Saudi Arabia
    South Africa
    Turkey
    United States
    Belgium
    France
    Germany
    Greece
    Ireland
    Italy
    Netherlands
    Spain
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 91
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 8
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 51
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 32
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 160
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Study will remain open for 10y from FPFV or until study treatment becomes commercially available and is reimbursed in the respective indication or until enrolled patients no longer need treatment with SEG101, whichever comes first. If SEG101 is not commercially available to patients at end of study, Novartis will ensure that patients benefitting from treatment continue to have access to crizanlizumab without interruption of treatment in accordance with local regulation.
    El estudio permanecerá abierto 10 años desde la FPFV o hasta que el tratamiento del estudio se comercialice y se reembolse en la respectiva indicación o hasta que los pacientes reclutados ya no necesiten tratamiento con SEG101,lo que suceda primero.Si SEG101 no se comercializa para pacientes al final del estudio,Novartis se asegurará de que los pacientes que se beneficien del tratamiento continúen teniendo acceso a crizanlizumab sin interrupción del tratamiento de acuerdo con la normativa local.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-24
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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